ISRCTN14212905进行中（未招募）2 期
DEFINE - Evaluating therapies for COVID-19
niversity of Edinburgh0 个研究点目标入组 200 人开始时间: 2020年7月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34911721/ (added 17/12/2021) 2022 Preprint results in https://doi.org/10.1101/2021.12.21.21267983 (added 07/11/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35152152/ (added 07/11/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Main inclusion criteria (all appendices)
- •1. Provision of informed consent
- •2. Aged at least 16 years
- •3. COVID-19 positive test (lateral flow followed by confirmatory PCR or PCR only) result within last 14 days
- •4. If the patient is of child bearing potential*, or is a male with a female partner with child bearing potential the patient, and their partner(s), agree to use medically-accepted contraception.
- •(added 22/09/2022) Appendix 3 Specific inclusion criteria:
- •For this Appendix all above inclusion criteria must be met. In addition, the following criteria must also be met:
- •1. Patient deemed capacitated to provide informed consent for themselves.
- •2. Maintaining oxygen saturations of =92% at time of screening and for 24 hours prior to commencement of infusion.
- •3. If the patient is of child bearing potential, or is a male with a female partner with child bearing potential, the patient, and their partner(s), agree to use a highly effective method of contraception for 4 weeks following the date of the infusion. Methods considered highly effective are those that achieve a failure rate of less than 1% per year when used consistently. This includes:
- •3.1. Combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation
- •Intravaginal
- •Transdermal
- •3.2. Progesterone-only hormonal contraception associated with inhibition of ovulation:
- •Implantable
- •3.3. Intrauterine device (IUD)
- •3.4. Intrauterine hormone-releasing system (IUS)
- •3.5. Bilateral tubal occlusion
- •3.6. Vasectomised partner
- •3.7. Sexual abstinence
排除标准
- •1. Current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled cardiac disease (NYHA class IV), uncontrolled renal disease (eGFR < 30 mL/min/1.73 m²), severe liver dysfunction (ALT/AST > 5x ULN) or bone marrow failure (Hb < 8g/dL AND ANC < 0.5 mm³ AND platelet count <50,000 µL)
- •2. Women who are pregnant or breastfeeding.
- •3. Participation in another clinical trial of an investigational medicinal product (CTIMP)
- •4. Known hypersensitivity to the IMP or excipients.
- •5. Pre-existing or concomittant use of off-label treatments for COVID-19
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